Singapore to allow sale of Huang Lian and Huang Bai

From January 1,
2013, the Health Sciences Authority (HSA) will allow the sale of Chinese
proprietary medicines (CPM) containing berberine in Singapore.

This was announced on Saturday by Health Minister Gan Kim Yong at a forum on traditional Chinese medicine by overseas experts.

Berberine
is an alkaloid naturally present in some herbs such as Rhizoma coptidis
and Cortex phellodendri, and used in traditional Chinese medicine (TCM)
for its "heat-clearing" and "dampness-drying" properties.

The
prohibition of the use of berberine, as controlled under the Poisons
Act, was implemented by the Ministry of Health in 1978, arising from
local safety concerns that berberine could cause severe jaundice and
brain damage in glucose-6-phosphate dehydrogenase (G6PD) -deficient
babies.

G6PD deficiency is a genetic disorder that results in
the breakdown of red blood cells leading to anaemia, when one is exposed
to certain medicines or chemicals.

The HSA, together with its
expert committees, has been monitoring the situation and conducting
ongoing scientific reviews on the safety profile of berberine.

This
includes literature review of scientific publications on the safety of
berberine, and surveillance of adverse reactions reported in other
places which practise TCM such as China, Taiwan and Hong Kong.

The
feedback from the local TCM community and developments in the local
regulatory landscape were also factors considered in the review of
berberine.

The latest review conducted by the Berberine Expert
Panel indicates that there are no major safety concerns when berberine
is used appropriately.

However, it cautioned that it should still
be avoided in infants, G6PD-deficient individuals of all ages, pregnant
and breastfeeding women.

Professor Ng Han Seong, chairman of
the Berberine Expert Panel, said: "There are various factors that led to
the lifting of the ban. I think one is... (that the) Ministry of Health
started, in 1965, a screening process for all babies... so we know
which babies are deficient in G6PD. And so the mothers were given
adequate education and all the warnings of the use of herbs."

Some physicians have hailed the authorities' move to lift the ban.

Wong
Chin Nai, president of the Singapore Chinese Physicians' Association,
said: "In future, we can freely use herbs containing berberine to treat
patients. This can hopefully bring about better outcomes and benefit
patients."

Based on the recommendations of the Berberine Expert
Panel and taking into consideration that there are sufficient safeguards
in place, HSA, in consultation with MOH, will adopt a phased approach
in the lifting of the prohibition on berberine in Singapore.

For
a start, the use of CPM containing berberine, for example in capsules,
oral liquid preparations, powders and granules used by TCM practitioners
in their dispensing, would be allowed with effect from January 1, 2013.

In the absence of major safety issues, the HSA will review the
possible further lifting of prohibition on Chinese herbs containing
berberine by 2015.

HSA said to safeguard public health, CPM
containing berberine will be subjected to the current regulatory regime
whereby HSA will review the safety and quality of these preparations
before they are placed in the local market.

Additional labelling
requirements, in the form of appropriate cautionary statements to warn
against use in infants, G6PD-deficient individuals of all ages, pregnant
and breastfeeding women, will be imposed on these products.

With the lifting of the ban, HSA will continue to monitor the situation closely for any occurrence of adverse reactions.

In
addition, educational programmes to TCM practitioners to share on
adverse reactions reporting and the precautions that should be taken
when using CPM containing berberine will be conducted.

HSA will
also engage the TCM industry to provide them with the relevant safety
information, so as to reach out to Chinese medical halls and retailers,
as well as conduct dialogue sessions with the industry on the relevant
technical requirements for these CPM.